About this trial
Submental fat accumulation, commonly known as a "double chin," is a frequent aesthetic complaint affecting the lower face and neck and is often associated with aging, weight gain, or a genetic predisposition (1). It develops from excess fat deposition in the superficial (pre-platysmal) and deep (post-platysmal) compartments of the neck (2), and can persist even in individuals of normal body weight owing to localized adipocyte hypertrophy that is resistant to diet and exercise (1). A large United States survey of adults aged 18-65 years found that 47% of respondents reported being bothered by the appearance of the area underneath their chin (3), and submental fullness has been consistently linked to lowered self-esteem and negative self-perception that motivate patients to seek treatment (1).
Several objective grading systems have been developed to standardize submental fat assessment. The Clinician-Reported and Patient-Reported Submental Fat Rating Scales, validated during the pivotal ATX-101 clinical trials, and an ethnicity-specific reference-photograph set derived from this scale later achieved inter-rater kappa values between 0.70 and 0.91 (4). Newer severity tools, including the Clinician Submental Fat Scale (5) and the Clinician-Chin Assessment Tool (6), have also been used to stratify patients before enrollment in pharmacologic trials.
Management options for submental fat span a wide spectrum. Injectable deoxycholic acid lipolysis has produced a significant reduction of submental fat in randomized placebo-controlled trials and meta-analyses, with a tolerable and mostly transient adverse-event profile, although a potential industry-sponsorship bias has been raised across the available trials (2). A newer injectable lipolytic agent achieved comparable improvement on clinician- and patient-reported scales, together with objective volume reduction on magnetic resonance imaging, in a large randomized Chinese cohort (7).
Cryolipolysis has similarly demonstrated efficacy for submental fat reduction, with pooled data from multiple pre-post studies showing a mean fat-thickness reduction of about 2.8 mm and a favorable safety profile (8), a finding corroborated by three-dimensional imaging analyses showing measurable volumetric loss and high patient satisfaction (9). Other non-invasive energy-based approaches, including combined focused-electrical-stimulation and radiofrequency devices, have been shown histologically to induce adipocyte apoptosis in the submental region (10). For patients with marked skin laxity or advanced neck-laxity grades, surgical techniques such as submental liposuction with platysma plication or resection remain the treatment of choice, as demonstrated in a recent submentoplasty cohort (10).
Given the absence of local Egyptian data comparing the full spectrum of double chin management options and the lack of information on the true burden of this condition among Egyptian patients, this cohort study is designed to systematically evaluate patients with submental fullness at Assiut University Hospital and to compare the effectiveness, safety, and patient satisfaction of the different available modalities, in order to generate evidence-based, locally relevant treatment guidance
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult patients ≥ 18 years of age, either sex.
Presenting with a cosmetic complaint of submental fullness/double chin, of any severity grade.
Willing to give informed consent and to complete the scheduled follow-up visits.
Able to undergo standardized clinical photography and, where applicable, ultrasound assessment.
Disqualifiers
• Previous submental surgical or minimally invasive procedures (liposuction, cryolipolysis, deoxycholic acid injections, thread lifting, energy-based device treatment).
Pregnancy or lactation.
Uncontrolled systemic disease (uncontrolled diabetes mellitus, bleeding/coagulation disorders, active malignancy).
Active skin infection, keloidal tendency, or dermatologic disease within the submental treatment field.
Trial population
patients Presenting with a cosmetic complaint of submental fullness/double chin, of any severity grade.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
The degree of reduction in submental fat
The degree of reduction in submental fat, measured objectively as the change in: cervicomental angle in degree
Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: